Mylan, Gilead partner to expand access to hepatitis C treatments

PITTSBURGH and HYDERABAD, India — Mylan announced that its subsidiary, Mylan Labs Limited, has signed an agreement with Gilead Science under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single-tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the name Sovaldi.

The countries that fall within the terms of the agreement account for more than 100 million people living with hepatitis C. Mylan will receive a technology transfer allowing it to manufacture low-cost versions of the medicines, the company stated.

"Hepatitis C is a growing public health problem in developing countries, with Central and East Asia and North Africa among the regions most affected by this disease," Mylan CEO Heather Bresch said. "Unfortunately, patients in these regions often lack access to critical and effective treatments. This agreement with Gilead will allow Mylan to provide early access to a more affordable version of Sovaldi, helping to meet the unmet medical needs of the millions of patients in developing countries who do not currently have access to this life-saving medicine."

Sofosbuvir was approved by the Food and Drug Administration in December 2013.

HOUSTON — Sharps Compliance Corp. and MedReturn on Monday announced that they have joined forces to launch MedSafe, a patent-pending solution for the safe collection, transportation and proper disposal of unwanted and expired prescription medications, including controlled substances.

The MedSafe system is designed to meet or exceed the requirements of the new regulations issued by the Drug Enforcement Administration implementing the Secure and Responsible Drug Disposal Act of 2010, which becomes effective Oct. 9. The MedSafe system is a safe, cost-effective and operationally efficient system designed for long-term care facilities, pharmacies, local law enforcement, narcotic treatment programs, hospitals and clinics with onsite pharmacies.

The MedSafe solution consists of a collection receptacle manufactured by MedReturn, coupled with Sharps Compliance’s return logistics system and onsite disposal via incineration, the DEA and Environmental Protection Agency recommended method for disposal of medications. MedReturn is the leading manufacturer of drug collection units utilized by licensed law enforcement and is currently being used in 49 states.

“The MedSafe system [facilitates] the collection of both non-controlled and controlled substances in a standard, safe and cost-effective manner," said David Tusa, president and CEO Sharps Compliance. "[W]e believe the MedSafe solutions will save our healthcare customers money and create much needed operational efficiencies when compared to traditional methods of disposing of dispensed controlled substances," he said. “The MedSafe system also facilitates collection of unused and unwanted consumer medications including controlled substances at participating retail pharmacies. This will provide consumers with a convenient method of unused medication disposal while ridding homes and medicine cabinets of potentially harmful drugs. We believe the retail pharmacies will see the MedSafe system as a value added service that could be offered to their customers and patients while driving foot traffic.”

Each MedSafe unit is tested under the standards established by Underwriters Laboratories, has a tamper-proof, one-way drop and comes with a removable serialized and trackable inner liner for safe transportation and disposal. Access to the inner liner is protected by a double-locked door until removal by authorized personnel. Inner liners returned to the Sharps Compliance disposal facility will be processed and treated via incineration, leaving the medication non-retrievable as required by the Act. The 18-gallon MedSafe unit is designed for lower volume locations such as a long term care facility. The 38-gallon MedSafe unit is designed for collection sites with larger volumes such as a retail pharmacy.

In addition to a collection receptacle, the Act authorizes the use of a mailback solution for the proper disposal, transportation and treatment of unused medications including controlled substances. The mailback would be designed for use in the long-term care (on behalf of their patient), hospice and consumer markets.

“We are also working with the United States Postal Service to convert our existing TakeAway Environmental Return System solution such that it meets the requirements of the new DEA rules thereby allowing the collection, transportation and destruction of unused medications including controlled substances," Tusa said. "We have sold well over one million of our current TakeAway Environmental Return System solutions over the past five years and believe we are well-positioned to be a leader in the sale of the new mailback solutions designed to meet the new DEA rules.”

WASHINGTON — Among those with diabetes, patient-focused, collaborative care that includes pharmacists can positively impact health outcomes, particularly in underserved or uninsured populations, according to the newly released results of APhA Foundation’s Project IMPACT: Diabetes.

The results of the APhA Foundation’s Project IMPACT: Diabetes, published in the Journal of the American Pharmacists Association, demonstrate how pharmacists and other healthcare providers can work together to successfully empower patients disproportionately affected by diabetes to achieve improved clinical outcomes.

Two peer-reviewed articles, released in an online-first edition of JAPhA, collectively highlight the clinical and process outcomes, as well as the unique characteristics of the patients and care delivery in the local communities that participated in the project. A print version of both articles also will appear in the September/October issue of JAPhA.

More than 2,200 patients received care during Project IMPACT: Diabetes study, and data analysis indicates that the population experienced a statistically and clinically significant decrease in A1C, a key indicator of the severity of diabetes, after receiving team-based diabetes care that included pharmacists. The results demonstrate how patient-focused, collaborative care that includes pharmacists can positively impact health outcomes, particularly in underserved or uninsured populations.

Project IMPACT: Diabetes was launched in 2010 with support from the Bristol-Myers Squibb Foundation’s Together on Diabetes initiative. In an effort to enhance access to quality health care, the project integrated pharmacists into diabetes care teams in 25 diverse communities with high incidences of diabetes or populations of patients with uncontrolled diabetes or limited access to quality health care. Pharmacists met one-on-one with patients to provide clinical services, including targeted education about diabetes, guidance on proper medication use and coaching to achieve lifestyle changes. The communities were located in 17 states across the country and included care delivery within federally qualified health centers, community pharmacies, free clinics, physician offices and employer worksites.

All participating communities included pharmacists on the diabetes care team, collected a minimum dataset related to the care that was being delivered and employed the APhA Foundation’s Patient Self-Management Credential for Diabetes to customize care delivery based on the patient’s baseline knowledge about diabetes. The communities were given flexibility to customize additional care strategies in order to best meet the needs of their patients. Approaches outlined in JAPhA include group education classes, joint provider visits, grocery store tours, cooking classes and transportation incentives. One year following the end of the patient care study period, 96% of communities report sustaining team-based care that includes pharmacists’ patient care services.

The members of each healthcare team collaborating with pharmacists were as diverse as the implementation strategies and patient populations. Across the project 126 pharmacists, 96 physicians, 37 nurse practitioners, 22 dietitians, 19 patient or health advocates, 11 social workers and more than 100 other various healthcare team members were engaged in providing collaborative care. The final multi-level modeling statistical analysis of the clinical data results controlled for differences between each community. Results from Project IMPACT: Diabetes show that patient health outcomes can improve through team-based care that includes pharmacists and that the model can be sustainably implemented in many different practice settings.

Pulitzer Prize-winner Peggy Noonan, former Florida Gov. Jeb Bush and singer Diana Ross now feature on the schedule for the National Association of Chain Drug Stores Annual Meeting, slated for April 21-24 in Palm Beach, Fla.

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